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Calidi Biotherapeutics to Present New Data on Its Differentiated Approach to In Situ T-Cell Engagers Including a New Candidate Targeting TROP-2 at the AACR Annual Meeting in April 2026

On April 1, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will demonstrate new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment (TME).

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 SA, a known T and NK-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the AACR (Free AACR Whitepaper) meeting will showcase RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail may overcome these historical limitations.

The Company is developing a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"We continue to advance the RedTail platform through our lead asset, CLD-401, and now through our work with T-cell engagers," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads in a targeted fashion to distal sites of disease through systemic administration."

"The data we will present at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics likes cytokines and T-cell engagers and profoundly alter the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The ability of the RedTail platform to induce high levels of expression of its genetic payloads only at the tumor can potentially overcome many of the limitations currently seen with cytokine and T-cell engager therapies."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 1, 2026, View Source [SID1234664120])

Adagene Reports Full Year 2025 Financial Results and Provides Corporate Update

On April 1, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2025 and provided corporate updates.

"Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "The 10 mg/kg data reported at ASCO (Free ASCO Whitepaper) have now matured into the classic long survival tail of CTLA-4 inhibition. By significantly mitigating severe toxicities, patients remain on therapy longer, allowing CTLA-4-mediated intratumoral Treg depletion, alongside PD-1-mediated reinvigoration and CTLA-4-mediated priming of effector T cells, to drive durable disease control. Importantly, these data provide a clear, de-risked read-through to the 20 mg/kg dose, which already shows an encouraging 29% ORR with median duration of response not yet reached.

"Supported by Fast Track Designation and FDA alignment under Project Optimus, we are on track to finalize the optimal combination dose regimen for a potential MSS colorectal cancer registrational trial. The expanded therapeutic window also helps to establish muzastotug as a foundational combination backbone. At AACR (Free AACR Whitepaper), we will showcase this potential with data from triplet regimens—combining with fruquintinib in 3L+ MSS CRC, alongside results from the Morpheus Liver study evaluating a triplet of muzastotug, atezolizumab, and bevacizumab versus atezolizumab and bevacizumab alone in first-line HCC. These readouts underscore our ability to safely unlock deeper responses in hard-to-treat tumors."

2026 OBJECTIVES & CASH RUNWAY INTO EARLY 2028

· Data update from the ongoing Phase 1b/2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts

· Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

· Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

· Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

· Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

· Establish additional collaboration/licensing agreements.

With cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, Company expects a cash runway extending into early 2028.

PIPELINE HIGHLIGHTS

AMERICAN ASSOCIATION FOR CANCER RESEARCH 2026 PRESENTATIONS

The following abstracts have been selected for presentation at AACR (Free AACR Whitepaper) 2026:

1) Title: Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer

This poster will provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

2) Title: Results from the phase 1b/2 Morpheus Liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm

This poster will share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of liver cancer.

3) Title: Preclinical characterization of XB404, a masked anti-ROR1/2 antibody-drug conjugate

Partner Exelixis will present preclinical data from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects.

ONGOING COLLABORATIONS

· Sanofi: Invested up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with Sanofi’s SAR445877 (PD-1 x IL-15 fusion protein) in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody discovery program.

· Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.

· Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

· ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

· Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$74.5 million as of December 31, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.1 million as of December 31, 2025 from US$ 18.2 million as of December 31, 2024. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

Net Revenue:

Net revenue was US$7.7 million for the year ended December 31, 2025, compared to US$0.1 million in 2024. The increase of approximately 7,333% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi, ConjugateBio and Third Arc Bio, respectively.

Research and Development (R&D) Expenses:

R&D expenses were US$22.0 million for the year ended December 31, 2025, compared to US$28.8 million in 2024. The decrease of approximately 23% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.1 million for the year ended December 31, 2025, compared to US$7.3 million in 2024. The decrease was mainly a result of cost-control measures.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$17.6 million for the year ended December 31, 2025, compared to US$33.4 million in 2024.

Ordinary Shares Outstanding:

As of December 31, 2025, there were 59,231,993 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

ADG126- Phase 1b/2 data:

· As presented at ASCO (Free ASCO Whitepaper) 2025, muzastotug showed 29% (6/21) confirmed overall response rate (ORR) in the combined 20 mg/kg dose cohorts.

· Among 41 patients in the combined 10mg/kg dose cohorts, median overall survival (mOS) was 19.4 months with a 17.8-month median follow-up, which compares favorably to 11-12 month mOS from fruquintinib Phase 3 trials in the same population1

· Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 27% in the 20 mg/kg cohorts, which were generally transient and manageable.

· Updated data demonstrate the durability of response and further support the optimized therapeutic index profile of muzastotug, which overcomes well-known dose-limiting toxicities of other CTLA-4 inhibitors at 10-20-fold higher doses2, to provide potentially improved efficacy.

· Randomized Phase 2 trial enrollment ongoing, with results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

(Press release, Adagene, APR 1, 2026, View Source [SID1234664119])

Medicilon Signs Five-Year Strategic Cooperation Agreement with BioPartners X to Jointly Promote Innovative Drug R&D

On March 31, 2026 Medicilon reported to have signed a long-term strategic cooperation framework agreement with BioPartners X. Mr. Gong Huimin, Chairman and CEO of BioPartners X, Dr. Liu Tong, Chief Scientist, Mr. Luo Wusong and Mr. Xu Changlu, Vice Presidents of Strategic Investment, and Mr. Li Ao, Non-Clinical Director, together with Dr. Chen Chunlin, Founder and CEO of Medicilon, and Ms. Wang Mingying, Senior Director of Business Development, attended the signing ceremony.

At the signing ceremony, both parties held in-depth discussions on the directions of future cooperation. BioPartners X has strong capabilities in the transformation of scientific research achievements from universities. With a development vision of building a pipeline of 100 innovative drug IND candidates, BioPartners X boasts enormous innovation potential and broad development prospects. Medicilon and BioPartners X have agreed to fully share resources in business development, industry channels and industrial information, further expand cooperation scenarios, enhance collaboration efficiency, and jointly build a highly interconnected ecosystem for innovative drug research and development. Within the agreed cooperation period, the two parties will focus on innovative drug R&D for major diseases, with the goal of achieving 5 IND submissions, and jointly set a benchmark for cooperation between CROs and innovative pharmaceutical companies.

Complementary Advantages for Long-Term Cooperation
Committed to the ultimate mission of "Making Human Life Better" and adhering to long-termism and the Long March spirit, BioPartners X focuses on therapeutic areas including nephropathy, autoimmune diseases, metabolic diseases, central nervous system disorders, infectious diseases and oncology. It implements its strategic goals through the "Three Concentrations" methodology: concentrating global scientific research strength, global talent resources, and global capital. By integrating core forces in global scientific research, investment and financing, and pharmaceutical operation, the company aims to develop 100 innovative drugs for humanity, benefit global human health and become a world-class innovative pharmaceutical company rooted in China.

As a leading one-stop preclinical R&D platform, Medicilon offers a comprehensive service system covering drug discovery, CMC, preclinical research and IND registration and filing. With international GLP certifications and extensive project experience, Medicilon has helped over 2,000 global clients accelerate new drug development.

Hand in Hand to Accelerate Innovative Drug R&D
During the cooperation period, Medicilon will provide BioPartners X with full-chain R&D services covering four dimensions:
· Drug Discovery: Chemistry, custom synthesis (FFS/FTE), bioactivity screening, protein expression, purification and crystallization, etc.
· Pharmaceutical Research: Full-process services including API process, quality and stability research and filing, as well as formulation process, quality research and production, etc.
· Preclinical Research: Drugability assessment, pharmacodynamics, pharmacokinetics and toxicology studies (single/multiple-dose toxicity, safety pharmacology, reproductive toxicity, etc.).
· Turnkey Services: Integrated services from drug discovery to preclinical research for IND registration and filing, accelerating project progress throughout the cycle.
Building on mutual recognition from prior cooperation, the two parties will integrate resources and collaborate efficiently to shorten new drug R&D cycles, systematically address unmet medical needs.
Chunlin Chen,Chairman and CEO of Medicilon

Medicilon will fully serve as a solid backing for BioPartners X in its innovative drug R&D journey and provide all-round support as it advances toward developing 100 innovative drugs. Leveraging its advantages in one-stop full-process R&D services, Medicilon will coordinate high-quality resources, deeply align with BioPartners X’s R&D needs, and efficiently promote the implementation and effectiveness of cooperative projects.

Huimin Gong,Chairman and CEO of BioPartners X

Medicilon’s technological strength, project experience and service quality in new drug R&D will provide strong support for BioPartners X’s innovative drug pipeline layout and help steadily achieve its long-term strategic goals.

This strategic cooperation marks a crucial step for both parties to base themselves on industrial development and deepen long-term collaboration. Going forward, Medicilon and BioPartners X will uphold long-termism to deeply engage in innovative drug R&D, continuously expand cooperation dimensions.

(Press release, Shanghai Medicilon, MAR 31, 2026, View Source [SID1234664439])

ABK Biomedical and MURR Forge Long-Term Partnership to Advance Breakthrough Cancer Therapy

On March 31, 2026 ABK Biomedical and the University of Missouri Research Reactor (MURR) are powering the next generation of cancer treatment, reported to have signed a long-term agreement naming MURR as the primary irradiation partner for Eye90 microspheres, an advanced Yttrium-90 (Y-90) radioembolization therapy designed to fight liver cancer.

This strategic partnership builds on seven years of collaboration between ABK and MURR, a relationship that has already driven critical progress in Eye90 development and is fueling the recently-fully-enrolled Route90 FDA IDE clinical trial for hepatocellular carcinoma (HCC). By formalizing this continuing alliance, ABK secures a reliable and scalable production partner for Eye90 microspheres and brings life-saving treatments closer to patients worldwide.

"MURR is internationally recognized for its leadership in nuclear research and medical isotope production," Mike Mangano, President and CEO of ABK Biomedical, said. "This agreement marks a major milestone as we transition from clinical development to commercialization. It underscores our commitment to Columbia, Missouri, and our confidence in MURR’s unmatched expertise."

The agreement also reflects a shared vision for advancing medical innovation. Together, ABK and MURR are creating a foundation for global access to novel cancer therapies, combining ABK’s pioneering device technology with MURR’s proven capabilities in isotope production and research excellence.

"Today’s agreement reflects Mizzou at its very best — bringing together world-class research, industry leadership and unmatched reactor capabilities to solve some of the most urgent challenges in human health," University of Missouri President Mun Choi said. "Our partnership with ABK Biomedical strengthens Missouri’s role as a national leader in medical innovation and delivers direct benefits to patients and communities across the state. This kind of collaboration accelerates discovery and improves lives here at home and around the world."

"This partnership represents a powerful win for the entire state of Missouri," UM Board of Curators Chair Todd Graves said. "By expanding high-tech research and advanced medical production right here in Columbia, we’re strengthening our economy and delivering innovations that improve health outcomes for Missouri families. Investments like this ensure that our university system continues to drive growth and opportunity in all 114 counties — fueling progress that benefits every community we serve."

"At MURR, our mission is to deliver absolute reliability in the production of life‑saving medical isotopes, and this partnership demonstrates exactly why our reactor is indispensable to patients in Missouri and around the world," Matt Sanford, executive director of MURR, said. "With decades of experience operating at the highest standards, MURR provides the consistency, capacity and scientific rigor required to bring breakthrough therapies like Eye90 to market. We’re proud that our work not only fuels cutting‑edge innovation but also strengthens Missouri’s position as a global leader in nuclear medicine."

Mizzou began a multiyear, strategic partnership with ABK Biomedical in 2019 and is currently the only location in the United States producing Y-90 for clinical and commercial use.

(Press release, ABK Biomedical, MAR 31, 2026, View Source [SID1234664230])

AAVivo to Present Groundbreaking In Vivo CAR-T Data at ASGCT 2026 Annual Meeting in Boston

On March 31, 2026 AAVivo, a Delaware-registered biotechnology company focused on next-generation AAV-based gene therapies and supported by Virovek, reported that it will host a sponsored symposium at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11–15, 2026, in Boston, Massachusetts.

The symposium, titled "Breaking Barriers in In Vivo CAR-T Therapy: CD3scFv-Engineered AAV Capsids Drive Superior CAR-T Cell Generation and Complete Tumor Eradication," will showcase compelling new preclinical data from AAVivo’s proprietary AAVTCeT platform.

During the session, the company will present evidence demonstrating how its CD3scFv-engineered AAV capsids enable highly efficient in vivo CAR-T cell generation, resulting in complete tumor eradication in preclinical models. This innovative approach addresses major limitations of traditional ex vivo CAR-T therapies, including complex and costly manufacturing processes, limited patient accessibility, and scalability challenges.

"Presenting at ASGCT (Free ASGCT Whitepaper) 2026 provides an important platform to share our progress toward transforming CAR-T therapy," said Haifeng Chen, PhD, CEO of AAVivo. "Our AAVTCeT platform has the potential to deliver an off-the-shelf, in vivo solution that could significantly improve patient outcomes and broaden access to life-changing cell therapies. We look forward to engaging with the gene and cell therapy community and potential partners in Boston."

Symposium Details

Title: Breaking Barriers in In Vivo CAR-T Therapy: CD3scFv-Engineered AAV Capsids Drive Superior CAR-T Cell Generation and Complete Tumor Eradication
Date & Time: Friday, May 15, 2026 | 10:15 – 10:45 AM
Location: Room 109AB, Thomas M. Menino Convention & Exhibition Center, Boston, MA
Format: Sponsored Symposium (open to ASGCT (Free ASGCT Whitepaper) 2026 registered attendees; also livestreamed via the ASGCT (Free ASGCT Whitepaper) Events App)
The presentation will include an overview of the AAVTCeT platform technology, key preclinical efficacy and safety data, and the company’s development roadmap for clinical translation.

AAVivo is advancing its platform with the support of Virovek’s established AAV expertise to develop more accessible and cost-effective genetic medicines.

(Press release, AAVivo, MAR 31, 2026, View Source [SID1234664118])